The controversy over conflicts of interest for Jeff Shuren, formerly the director of the U.S. FDA’s device center, reached Capitol Hill and may lead to an executive branch investigation into the matter.
In recent years, the U.S. Congress has come to rely unduly on continuing budget resolutions to fund government operations, and fiscal year 2024 is no exception. The current continuing resolution (CR) for the FDA budget is set to expire March 1, but there is concern that Congress will resort yet again to a CR to cover the balance of fiscal 2024, a predicament which suggests that the FDA’s appropriations may be flat relative to fiscal year 2023.
The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties regarding FDA’s authorities for managing drug shortages.
The intellectual property waivers for American vaccines for the COVID-19 pandemic are still controversial, but the World Health Organization (WHO) is nonetheless seeking a similar set of waivers for therapies and tests for COVID. A subcommittee of the House Judiciary Committee met June 6 to review these waivers, and subcommittee chairman Darrell Issa (R-Calif.) said he intends to continue pushing legislation that would require the U.S. president to obtain congressional approval for agreeing to any such waivers in the future.
When it comes to cutting health care costs in the U.S., last year’s Inflation Reduction Act, with its inflationary rebates and direct Medicare negotiations, was just Act 1. Now lawmakers, in both the House and Senate, are feverishly working on bipartisan scripts for Act 2 that go beyond biopharma’s role in drug prices to taking on pricing issues across the health care sector.
With only a week to go before the Nov. 8, 2022 midterm election in the U.S., speculation is growing over what the 118th Congress will look like and what it will mean for the biopharma and med-tech industries. If Republicans flip either chamber, it would prevent either party from using the reconciliation process, which requires the barest majority in the Senate, to pass legislation such as the Inflation Reduction Act with its provisions giving the federal government some control over prescription drug prices.
A committee of the U.S. House of Representatives is moving forward with a bill that would extend Medicare telehealth provisions for two years after the end of the COVID-19 public health emergency, but the legislation lacks features to deal with fraud and abuse.
The U.S. House of Representatives voted June 8 to pass the legislation reauthorizing a number of user fee programs at the FDA, a welcome bit of good news for FDA-regulated industries. Nonetheless, there are several substantive differences between H.R. 7667 and the parallel Senate bill, differences that may take some doing to overcome before a final bill can be forwarded to the Oval Office.
The U.S. House of Representatives passed the COMPETES Act of 2022 in a narrow Feb. 4 vote that may help restore U.S. manufacturing of pharmaceuticals and the semiconductors that are critical for medical devices. However, the House bill also includes unrelated provisions such as a section dealing with health insurance costs, just one of several elements that are not seen in a similar Senate bill and which foreshadow a drag-inducing showdown between the two bills.
A number of members of the U.S. House of Representatives have penned a letter to the Centers for Medicare & Medicaid Services (CMS) in support of the Medicare Coverage of Innovative Technology (MCIT) rule, the second time in recent weeks the agency has heard from Congress. The net effect of these letters is to suggest that Cures 2.0, which would provide Medicare coverage of breakthrough devices, is not on solid footing, which if true would suggest that the Biden administration’s Advanced Research Projects Agency for Health (ARPA-H) is similarly endangered.
